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Comparability and Standardization of Controlled Allergen Challenge Facilities

NCT02543346 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 98

Last updated 2019-04-09

Study results available
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Summary

Allergen challenge facilities have been utilized for many years in clinical drug trials studying onset of action, proof of concept, duration of action, and efficacy. Each facility has somewhat different design characteristics and pollen dispersal technologies. Facilities are located in disparate geographic areas and have populations of participants who are sensitized to allergens unique to that area. Therefore, facilities have operated as single sites with little effort to evaluate facility comparability or to attempt standardization across facilities. The purpose of this study is to compare the two sites and assess whether the sites are able to achieve similar symptom scores.

Conditions

  • Allergic Rhinitis

Interventions

DRUG

Cetirizine

Participants will receive either cetirizine (10mg tablet, orally) or a placebo (sugar pill) at one of the two treatment visits.

OTHER

Placebo

Participants will receive either a placebo or cetirizine (10mg tablet, orally) at one of the two treatment visits

Sponsors & Collaborators

  • Biogenics Research Chamber, LLC

    collaborator INDUSTRY

  • Queen's University

    lead OTHER

Principal Investigators

  • Anne K Ellis, MD · Queen's University

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-02-29
Completion
2016-05-31

Countries

  • United States
  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02543346 on ClinicalTrials.gov